FSMA 2011 Progress Reports

The FDA intends to provide regular updates to inform the public and Congress on its progress in implementing the FDA Food Safety Modernization Act (FSMA). This summary does not reference all actions taken by FDA.

January 2011

Food and Drug Law Institute (FDLI) Hears about FDA Food Safety Modernization ActDeputy Commissioner for Foods Michael R. Taylor spoke to the FDLI Food Safety Conference, giving an overview of the recently signed food safety reform bill and calling for a continuation of the broad based, bi-partisan support that worked for its passage as critical for its successful implementation. Taylor said: “It is worth remembering how we got here. We got here with hard work, by confronting thorny issues, and most importantly of all, by working together.

Commissioner Hamburg Blog on FoodSafety.govFDA Commissioner Margaret Hamburg, M.D., posted a blog the day after President Obama signed the FDA Food Safety Modernization Act on what the new law would mean for American consumers. In her blog, the commissioner highlighted key FSMA provisions and noted the importance of resources for successful implementation of the law.

February 2011

Deputy Commissioner’s Speech on Safety of Imported FoodsDeputy Commissioner for Foods Michael R. Taylor spoke to an international audience of food safety experts at the Global Food Safety Conference in London, England, about the import provisions of FSMA. Taylor said: “The FDA Food Safety Modernization Act only heightens the imperative that we in the United States work in partnership with the global food safety community to meet the public’s high expectations for the safety of food, no matter its origin.”

March

Public Meeting on Safety of Imported FoodsFDA held on March 29 its first public meeting to hear stakeholders’ views on key provisions of FSMA. This one focused on the new responsibilities importers have under FSMA to assure the safety of the food they import. More than 500 persons participated in the meeting in person or via webcast. Specifically, the meeting gave stakeholders an opportunity to express their views on each of the four FSMA import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; Voluntary Qualified Importer Program; and Foreign Supplier Verification Program.

April 2011

Public Meeting on Preventive ControlsFDA held on April 20 its second public meeting to hear stakeholders’ views on key FSMA provisions. This one focused on preventive controls, a basic foundation of the FSMA food safety reform. Almost 500 persons participated in the meeting in person or via webcast. Specifically, FDA was seeking information on preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes.

Consumer-Friendly Web Search for RecallsAs required under FSMA, FDA launched April 4 a more consumer-friendly recall search engine on the FDA website. To provide greater ease of use for consumers, the search results provide data from news releases and other recall announcements in the form of a table. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm. The table also provides a link to the news release on each recall for more detailed information. The news releases were chosen as the source of information for the table because they provide the most up-to-date and user-friendly information about any recall.

Web Videos on Preventive Controls, Imports, Inspections/ComplianceThree FDA experts – Donald Kraemer of the Center for Food Safety and Applied Nutrition, David Elder of the Office of Regulatory Affairs, and Barbara Cassens of the San Francisco District Office – explained the new food safety law in short videos posted on the FDA FSMA webpage. The FDA experts addressed a number of the most frequently asked questions on preventive controls, imports and inspections/compliance.

FDA Posts 50 Frequently Asked Questions on new Food Safety Law Based on the extensive outreach to stakeholders, FDA developed a core list of 50 “frequently asked questions” about the key FSMA provisions. These questions will be updated on a regular basis as more decisions are made about the implementation of the new law. Stakeholders should routinely check the FDA FSMA website for these and other updates.

HHS Sends Congress First Annual ReportAs required under FSMA, HHS Secretary Sebelius submitted to Congress on April 6 the first annual “Report on Food Facilities, Food Imports, and FDA Foreign Offices.” The report briefly describes the scope of FDA’s responsibility and its activities in protecting the U.S. food supply under its jurisdiction. It also discusses how federal, state and local agencies cooperate with FDA in that effort. Baseline data are provided on the cost and number of domestic and foreign food facility inspections; the numbers of field samples analyzed to support FDA’s compliance actions; and FDA’s foreign posts and their staff who extend the international impact of FDA.

FDA Issues Guidance to Seafood Industry on Food Safety HazardsAs required under FSMA, FDA issued its updated guide to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards. FDA allows operators to use an alternative approach to control these hazards if such approach satisfies the requirements of the applicable statute and regulations. This is the fourth edition of the guidance, the FDA FSMA webpage also features a video introducing the guidance.

May 2011

Interim Final Rule on Prior Notice of Imported FoodOn May 5, FDA issued an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing potential risks of imported food into the United States.

Interim Final Rule on Criteria for Administrative DetentionOn May 5, FDA issued an interim final rule on criteria used to order administrative detention of food for human or animal consumption. The rule changes the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers.

Preventive Controls Guidance for Registered Human Food and Animal Food/Feed FacilitiesOn May 23, FDA announced the opening of a docket to obtain information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food/feed and specific processes. FDA established this docket to provide an opportunity for interested parties to provide information and share views that will inform the development of guidance on preventive controls for food and feed facilities that manufacture, process, pack, or hold human food or animal food/feed (including pet food. The comment period was extended to December 20, 2011.

June 2011

Public Meeting on Inspections and ComplianceFDA held on June 6 it third public meeting to hear stakeholders’ views on key FSMA provisions. This meeting focused on inspections and compliance. Almost 700 people participated in person or via webcast. The public had an opportunity to provide information and share views that will inform the development of guidance and regulations and/or the implementation of: Enforcement Authorities; Frequency and Targeting of Facility Inspections; Manner of Inspection in a Preventive Controls Environment; and Enhancement of the Reportable Food Registry (RFR). Comments are due to docket by July 6, 2011. FDA-2011-N-0366

July 2011

Six-Month Milestone in the Implementation of FSMAJuly 3 marks the six-month anniversary of the signing of the FSMA. On this date, FDA met two additional milestones required under the new law.Joint Anti-Smuggling StrategyFDA issued on July 3, a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS). The anti-smuggling strategy will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety. The FDA will work with U.S. Customs and Border Protection (CBP) to review historical data and better identify products, firms, and countries of origin to establish food smuggling targeting criteria. The FDA and CBP also will share information on import shipments and conduct joint examinations, when appropriate, to identify shipments that may contain smuggled food. When possible, the agencies will work together to publicize food smuggling enforcement actions to deter others from attempting similar acts.

Draft Guidance for Dietary Supplement IndustryFDA issued on July 3, draft guidance for the dietary supplement industry on assuring the safety of new dietary ingredients. The draft guidance clarifies agency expectations on new dietary ingredients for industry and is an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles. Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except in certain situations when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety. The draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications.

Authority to Suspend the Registration of Food FacilitiesOn July 3, the agency’s authority to suspend the registration of food facilities to prevent the import and export into the United States, or other intrastate or interstate distribution of food became effective. The FDA expects individuals responsible for registered food facilities to take steps to produce safe products. If those efforts fail, the facility should file a food report with FDA, voluntarily recall the affected product, and take action to keep products from reaching consumers. FDA may suspend the registration of a facility in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Administrative Detention of FoodsThis rule, issued in May, allows the FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, and went into effect on July 3. Under this rule, these products will not be sold or distributed while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product, is warranted.

MOU Signed with USDA On July 1, FDA and United States Department of Agriculture (USDA), National Institute of Food and Agriculture (NIFA), entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training, and other projects, as part of a Memorandum of Understanding with USDA’s Research, Education and Economics Agencies.

August 2011

FY 2012 Reinspection Fee Schedule and Outreach to Small BusinessesOn August 1, as required by FSMA, FDA announced the fiscal year (FY) 2012 fee schedule for certain domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections. The fees affect only those parties in the food and feed industry whose non-compliance results in a reinspection. Comments on FDA’s fees schedule and application of fees were to be submitted to docket Number FDA-2011-N-0528 by October 31, 2011, but the comment period has now been extended to November 30, 2011. Additionally, on August 1 FDA opened docket number FDA-2011-N-0529 seeking comments on the burden of the FSMA fees for small businesses. That docket was originally set to close on October 17, 2011, but the comment period has now been extended to November 30, 2011. The Agency has also recently published a guidance for industry on the implementation of the fee provisions. This guidance was announced in FDA docket number FDA-2011-D-0721. Comments can be submitted on the guidance at any time.

September 2011

FDA Makes 7 Grants To Build Food Safety CapacityFDA awarded seven grants in September 2011 to five land-grant universities and two training institutes to design, develop and disseminate food and feed safety training programs. These food safety capacity-building grants are aimed at developing the fully integrated food safety system called for by FSMA. The grants totaled $7.3 million and were awarded to: Auburn University, Iowa State University, North Carolina State University, University of California-Davis, and University of Tennessee-Knoxville, the International Food Protection Training Institute, and the National Environmental Health Association (working with Underwriter Laboratories).

Report to Congress on Food Emergency Response NetworkThe Food and Drug Administration published its FSMA-mandated report to Congress on the status of the Food Emergency Response Network, an integrated and secure network of 172 federal, state and local laboratories. The network is able to detect, identify, respond to and aid in recovery from emergencies as a result of a biological, chemical or radiological contamination of food.

Product Tracing Pilots LaunchedThe U.S. Food and Drug Administration announced September 7 that the Institute of Food Technologists (IFT), a nonprofit scientific society consisting of professionals engaged in food science, food technology, and related professions, will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.FSMA required the FDA to establish at least two pilot projects: one involving produce and one involving processed foods. The law also directs the FDA to establish recordkeeping requirements for high-risk foods to help in tracing products.The pilots will evaluate methods and technologies for rapid and effective tracing of foods, including types of data that are useful for tracing, ways to connect the various points in the supply chain, and how quickly the data are made available to the FDA.

November 2011

Outreach to Trade PartnersAs part of FDA’s continuing outreach efforts to international trade partners, Deputy Commissioner for Foods Michael R. Taylor delivered a major speech at the China International Food Safety and Quality Conference and Expo in Beijing, China, on November 2, 2011.

December 2011

FDA Partners with Industry, Academia on Preventive Controls AllianceIn anticipation of new rules under the Food Safety Modernization Act, the Food and Drug Administration, in partnership with industry and academia, announced the establishment of the Food Safety Preventive Controls Alliance (FSPCA) to provide a basic curriculum and associated training materials on preventive controls for human and animal food companies.The alliance will have members from FDA, local and state food protection agencies, the food industry and academia, and is funded by a one-year $1 million grant to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH), a nationally-recognized leader in food safety.